Armodafinil in Reducing Cancer-Related Fatigue in Patients with High-Grade Glioma

Basic Trial Information

Phase

Type

Age

Trial IDs

Phase III

Supportive care

18 and over

A221101NCI-2012-02020, N10C3, NCT01781468

Trial Description

Summary

This randomized phase III trial studies how well armodafinil works in reducing cancer-related fatigue in patients with high-grade glioma. Armodafinil may help relieve fatigue in patients with high-grade glioma.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory [BFI]) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

SECONDARY OBJECTIVES:

I. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.

II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.

III. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.

IV. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties.

Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed

Ability to complete questionnaire(s) by themselves or with assistance

Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician

Exclusion Criteria:

Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:

History of myocardial infarction

Unstable angina

Left ventricular hypertrophy

Mitral valve prolapse syndrome

Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration

Strong Inhibitors of CYP3A4:

> 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance

Indinavir (Crixivan)

Nelfinavir (Viracept)

Atazanavir (Reyataz)

Ritonavir (Norvir)

Clarithromycin (Biaxin, Biaxin XL)

Itraconazole (Sporanox)

Ketoconazole (Nizoral)

Nefazodone (Serzone)

Saquinavir (Fortovase, Invirase)

Telithromycin (Ketek)

Moderate Inhibitors of CYP3A4

> 2-fold increase in the plasma AUC values or 50-80% decrease in clearance

Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed

History of hypersensitivity to other psychostimulants

History of steroid psychosis

History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report

History of or active glaucoma

History of intractable epilepsy, or uncontrolled seizure disorder

Receiving any medications or substances that are inducers of CYP3A4; use of the following inducers are prohibited =< 7 days prior to registration

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